Eisai Resubmits Fycompa® (perampanel) to German Federal Joint Committee for Additional Benefit Assessment

 Eisai Resubmits Fycompa® (perampanel) to German Federal Joint Committee for                         Additional Benefit Assessment    PR Newswire    HATFIELD, England, May 12, 2014  HATFIELD, England, May 12, 2014 /PRNewswire/ --   Early resubmission positive step forward for first-in-class epilepsy drug in                                   Germany   Eisai has resubmitted its first-in-class epilepsy treatment Fycompa ^® (perampanel) to the German Federal Joint Committee (G-BA) for reassessment of its additional therapeutic benefits. This follows the G-BA decision in February that Eisai could resubmit their anti-epileptic drug (AED) for early reassessment. The new decision is expected to be published within 6 months. Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older. ^[1]   "We are very pleased that the G-BA has approved our request for an early benefit reassessment of Fycompa," commented Gary Hendler, President & CEO, Eisai EMEA. "The clinical benefit of Fycompa has been recognised in approximately 3,000-4,000 people with epilepsy in Germany since its launch in September 2012 and our first concern throughout this process has been for them. We firmly believe that innovative treatment options are desperately needed for people with this serious condition and believe that the G-BA will reconsider its original position and not effectively deny very ill patients the clinical benefit that Fycompa offers people with partial epilepsy again."   Eisai temporarily suspended perampanel from distribution in Germany (Aussetzen des Vertriebes) in June 2013 following the previous negative G-BA ruling and established a programme for continued supplyof perampanel (Fycompa) free of charge to German pharmacies through individual import (managed by Clinigen Group plc) to ensure that people with epilepsy continue to receivetreatment with perampanel (Fycompa), whilst the G-BA consider the resubmission.  "There still remains a very high need for effective new treatments to reduce seizures in patients with refractory partial epilepsy in Germany. The early resubmission of Fycompa for benefit reassessment is a positive step forward as it means that doctors and patients may soon be able to access a treatment option with proven clinical benefits through the usual way of distribution," commented Professor Bernhard Steinhoff, from Epilepsiezentrum Kork, Kehl-Kork, Germany.  In Germany, approximately one in every 200 people has epilepsy, which equates to an estimated 400,000 people in the country who live with the condition. ^[2] Epilepsy is one of the most common neurological conditions in the world. ^[3] The successful treatment of partial onset seizures remains a challenge as over 30% of patients do not achieve seizure freedom despite appropriate therapy with AEDs. ^[4]  Discovered and developed by Eisai in the UK and Japan, perampanel is the first and only approved AED in Europe with a mode of action that selectively targets AMPA receptors, thought to play a central role in seizure generation and spread. ^[5]  Eisai is a leading research and development based pharmaceutical company. The company's Corporate Philosophy is to give first thought to patients and their families, and to increase the benefits that health care provides to them. Eisai calls this philosophy human health care ( hhc ). Eisai believes that the hhc philosophy is its primary objective and that only through focussing on the needs of the patient and the wider global healthcare system that sales and earnings will be generated. Guided by our hhc philosophy, Eisai will continue to work to achieve sustainable enhancement of value through its business activities worldwide.  Notes  to  Edi to rs   About Perampanel   Perampanel is licensed in the European Union (EU) as an adjunctive treatment for people aged 12 years and older with partial-onset seizures, with or without secondarily generalised seizures. ^[1 ^]  Perampanel is a highly selective, non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling including epilepsy, neurodegenerative disorders, movement disorders, pain and psychiatric disorders. ^[1 ^]  Further information for healthcare professionals can be found at http://www.fycompa.eu   About Perampanel in Germany   Recently, the first multicenter practical experience with Perampanel in a larger series of consecutive patients with difficult-to-treat epilepsies from 9 specialized hospitals from Germany (7 centers) and Austria (2 centers) have been published. ^[6] Patients (54% female, mean age 38 years) were followed-up for treatment outcome for a minimum of 6 months. In half of the n=281 patients included, who received Perampanel mostly as add-on to a baseline therapy consisting of 2 or 3 AEDs (65%), seizure frequency was reduced by at least 50%. Seizure freedom was achieved in 15% of patients. Adverse events were reported by 52% of patients, with somnolence (24.6%) and dizziness (19.6%) being most frequently reported. The retention rate after 6 months was 60%. The mean Perampanel dosage was 7.7 mg. In some patients, a marked response could be observed at relatively low dosages, which is mooted by the authors as possibly pointing to a special sensitivity of those patients to the new mechanism of action of Perampanel. The authors award Perampanel some encouraging potential as an add-on AED in their conclusion.  About Epilepsy   Epilepsy is one of the most common neurological conditions in the world, affecting approximately one in every one hundred people in Europe, and an estimated 50 million people worldwide. ^[7] ^, ^[8] Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.  About Eisai EMEA in Epilepsy   Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa, Russia and Oceania (EMEA).  In the EMEA region, Eisai currently has four marketed treatments including:    *Fycompa ^® (perampanel) for use as an adjunctive treatment for partial     onset seizures, with or without secondarily generalised seizures, in     patients with epilepsy aged 12 years and older   *Inovelon ^® (rufinamide) for the adjunctive treatment of seizures     associated with Lennox-Gastaut Syndrome in patients > 4 years. (Inovelon     was originally developed by Novartis)   *Zebinix ^® (eslicarbazepine acetate) as adjunctive therapy in adult     patients with partial onset seizures, with or without secondary     generalisation. (Zebinix is under license from BIAL)   *Zonegran ^® (zonisamide) as monotherapy in adults and adjunctive therapy     in adults, adolescents and children aged six years and above with partial     onset seizures, with or without secondary generalisation. (Zonegran is     under license from the originator Dainippon Sumitomo Pharma)  About Eisai   Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care ( hhc ).  Eisai concentrates its R&D activities in three key areas:    *Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight     loss   *Oncology including: anticancer therapies; tumour regression, tumour     suppression, antibodies, etc.   *Vascular/Immunological reaction including: thrombocytopenia, rheumatoid     arthritis, psoriasis, inflammatory bowel disease  With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Norway, Portugal, Russia, Slovakia, Spain, Switzerland, Sweden, the Netherlands and the Middle East.  For further information please visit our web site http://www.eisai.co.uk  References   1. Fycompa. Summary of Product Characteristics (updated November 2013) http://www.medicines.org.uk/emc/medicine/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c12mg+film-coated+tablets/ [ http://www.medicines.org.uk/emc/medicine/26951/SPC/Fycompa+2mg%2c4mg%2c6mg%2c8mg%2c10mg%2c12mg+film-coated+tablets ]   2. Pfäfflin, M. und May, T. Wieviele Patienten mit Epilepsien gibt es in Deutschland und wer behandelt sie? Neurol Rehabil, 2000; 6, (2) 77-81.   3. ILAE/IBE/WHO, Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe 2010. Available at; http://www.ilae-epilepsy.org/Visitors/Documents/EUROReport160510.pdf (Accessed June 2011)   4. Brodie MJ et al, Neurology 2012; 78:1548-1554   5. Rogawski MA. Epilepsy Currents 2011;11:56-63   6. Steinhoff, B.J., et al., A multicenter survey of clinical experiences with perampanel in real life in Germany and    Austria. Epilepsy Res. (2014), http://dx.doi.org/10.1016/j.eplepsyres.2014.03.015  7. Epilepsy in the WHO European Region  http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [Accessed 10 April 2012].  8. Pugliatti M, et al. Epilepsia 2007: 48(12) 2224 - 2233.     Date of preparation: May 2014  Job code: Perampanel-UK2157  Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte Andrews, +44(0)7908-314-155/+44(0)7947-231-513, Cressida_Robson@eisai.net, Charlotte_Andrews@eisai.net ; Tonic Life Communications, Frances Murphy/Nicola Lilley, +44(0)207-798-9262 /+44(0)207-798-9905, frances.murphy@toniclc.com, nicola.lilley@toniclc.com  
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